Difference between revisions of "LII:LIMS and laboratory informatics questionnaire"
Shawndouglas (talk | contribs) (→1.4.2 Configuration and customization: Updated from questions to statements.) |
Shawndouglas (talk | contribs) m (Text replacement - "\[\[LIMS and laboratory informatics questionnaire(.*)" to "[[LII:LIMS and laboratory informatics questionnaire$1") |
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|- | |- | ||
! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px; width:800px;"| 1.0 '''Vendor information''' | ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px; width:800px;"| 1.0 '''Vendor information''' | ||
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==1.1 Vendor services== | ==1.1 Vendor services== | ||
{| | {| | ||
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! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''a.''' | | style="padding:5px; width:500px;" |'''a.''' The system tracks status and [[workflow]] of the [[Accessioning (medical)|accession]] throughout the laboratory lifecycle, from submission to final analysis, including receiving, diagnostic testing, diagnostic test result reporting, and billing. | ||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''b.''' The system supports [[LIMS feature#Barcode support|barcoded specimen]] labeling and tracking. | |||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''c.''' The system allows users to create, manage, and track viewable sample container schemata. | |||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''d.''' The system creates and maintains a unique electronic accession record for each accession received. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''e.''' The system supports standard-format digital picture and document upload and attachment to electronic accession records. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''f.''' The system supports a user-configurable, spreadsheet-style, templated ''multi-specimen'' ([[LIMS feature#Sample and result batching|batch]]) login without requiring additional programming. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''g.''' The system supports the modification of specimen or specimen batch information prior to actual ''multi-sample'' (batch) login. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''h.''' The system supports ad-hoc specimens not predefined in the specimen point list during ''multi-sample'' (batch) login. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''i.''' The system creates, saves, and recalls pre-login groups for routine samples to simplify recurring logins. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''j.''' The system streamlines the [[LIMS feature#Sample login and management|login]] of recurring sample projects. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''k.''' The system automatically [[LIMS feature#Label support|generates labels]] for recurring samples and sample groups. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''l.''' The system allows authorized users to generate user-definable or rules-based chain of custodies, worksheets, routing sheets, and custom labels upon sample login. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''m.''' The system provides a comprehensive view of all samples and projects in the system using a color-coded status view of the current and scheduled samples via user-configurable templates, all without requiring additional programming. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''n.''' The system includes [[LIMS feature#Environmental monitoring|environmental monitoring]] (EM) functionality or integrates with an external EM product. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''o.''' The system prevents a sample from being placed in a report queue until approved. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''p.''' The system includes comprehensive [[LIMS feature#Task and event scheduling|scheduling]], [[LIMS feature#Sample tracking|tracking]], and [[LIMS feature#Workflow management|flow management]] of samples, including across multiple sites. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''q.''' The system is capable of geographically organizing sample records and their associated tests for special analysis and reporting. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''r.''' The system allows authorized users to accept, cancel, re-run, and override attributes of one or multiple tests for a given sample. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''s.''' The system allows authorized users to review the available test types in the system, including their reference range and units of measure. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''t.''' The system has a "miscellaneous" test code to allow a test undefined in the system to be ordered and billed. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''u.''' The system allows authorized users to schedule routine samples on an hourly, daily, weekly, or monthly basis, allowing them to be enabled and disabled as a group. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''v.''' The system generates an hourly, daily, weekly, or monthly sample collection schedule from a scheduling database. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''w.''' The system schedules and [[LIMS feature#Project and/or task management|assign tasks]] based on available inventory and personnel. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''x.''' The system supports automatic assignment and scheduling of [[LIMS feature#Data and trend analysis|analysis requests]]. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''y.''' The system receives accession/analysis request information from web-enabled forms. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''z.''' The system electronically receives and processes collection and analysis request information and schedules from third parties. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''aa.''' The system has an inter-lab transfer function. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''ab.''' The system processes automated uploading of field-derived sample collection data. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''ac.''' The system allows users to handle billable and non-billable tests on the same accession. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''ad.''' The system supports tracking of shipping and receiving. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
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! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''a.''' | | style="padding:5px; width:500px;" |'''a.''' The system supports a variety of test protocols, each capable of storing test comments, test required, and special information like GCMS conditions or special objects associated with the test. | ||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''b.''' The system provides and enforces normal data range values for diagnostic tests. | |||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''c.''' The system includes default input values for diagnostic tests. | |||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''d.''' The system provides for a single test code requiring multiple analytes as targets. | |||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''e.''' The system allows authorized users to make a test code inactive across one or more sites while retaining it for audit and reporting purposes. | |||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''f.''' The system limits test code authorization to only qualified personnel and maintains their certification(s) to run assigned tests. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''g.''' The system supports and qualifies text-based tests. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''h.''' The system supports single-component tests such as pH, BOD, CD, etc. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''i.''' The system allows users to specify a single-component, multi-component, or narrative text test or group of tests, which represent all tests required. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''j.''' The system can effectively manage complex molecular testing protocols. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''k.''' The system can effectively manage genetic testing protocols. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''l.''' The system permits user-generated and modifiable calculations (based on a formulaic language) to be applied to all tests. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''m.''' The system distinguishes between routine and duplicate analysis. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''n.''' The system provides an overview of all outstanding tests/analyses for better coordination of work schedules. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''o.''' The system notifies analysts of applicable safety hazards associated with a sample, reagent, or test before testing begins. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''p.''' The system electronically transfers an item during testing from one functional area to another. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''q.''' The system's user interface displays visual indicators such as status icons to indicate a sample's status in the workflow. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''r.''' The system allows file transfer of data from instruments via intelligent interfaces or multi-specimen/multi-test ASCII files, with full on-screen review prior to database commitment. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''s.''' The system permits [[LIMS feature#Option for manual result entry|manual data entry]] into an electronic worksheet of test measurements and results. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''t.''' The system allows incorrectly inputted data to be manually corrected. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''u.''' The system prevents out-of-range and other critical results from being posted as final. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''v.''' The system provides colored visual indication of previously entered data as well as new data associated with a single sample when a result is entered, with the indicator changing color if the value is out of specification. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''w.''' The system allows automated or semi-automated data insertion. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''x.''' The system stores non-narrative textual results in searchable fields. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
|} | |} | ||
===1.4.5 Post-analysis and validation=== | ===1.4.5 Post-analysis and validation=== | ||
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" | {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" | ||
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! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''a.''' | | style="padding:5px; width:500px;" |'''a.''' The system updates sample/item status when tests are completed. | ||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''b.''' The system automatically reorders a test or orders additional tests if results don't meet lab-defined criteria, especially when the original sample is still available. | |||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''c.''' The system reads results from previously entered tests to calculate a final result and immediately displays the calculated result. | |||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''d.''' The system allows authorized users to review all analytical results, including pricing, spec violations, history or trend analysis by analyte, and comments. | |||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''e.''' The system graphically displays the results of one or more tests in a graph (normalized or otherwise) for the purpose of visualizing data or searching for possible trends. | |||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''f.''' The system allows on-screen review of the stored test result, diluted result with corrected method detection limits (MDLs), and qualifiers after running samples for multiple dilutions as in [[gas chromatography–mass spectrometry]] (GC-MS). | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''g.''' The system includes data mining tools for model learning, evaluation, and usage. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''h.''' The system displays the standard operating procedure (SOP) associated with each test result to ensure proper techniques were used. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''i.''' The system stores test-related analysis comments with the test. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''j.''' The system provides auto-commenting for common laboratory result comments. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''k.''' The system is capable of displaying entered order and test comments as an onscreen alert for testing and other personnel. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''l.''' The system provides for high-volume multi-component transfers of test results, with the ability to automatically match samples to data files in either a backlog mode or a designated file mode, to parse the data, and to review and commit the sample data. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''m.''' The system's results [[LIMS feature#Data validation|validation process]] accesses all information about a sample or group of samples, including comments or special information about the sample. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''n.''' The system's results validation process checks each result against its individual sample location specifications (both warning and specification limits). | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''o.''' The system supports validation at the analysis and sample level, while also prohibiting sample validation when analysis validation is incomplete. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''p.''' The system uses a menu-driven process for results validation. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''q.''' The system provides secure electronic peer review of results. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''r.''' The system clearly differentiates released preliminary data from fully validated results. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''s.''' The system validates/approves data prior to being moved to the main database. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''t.''' The system can hold all test results on a sample with multiple tests ordered on it until all work is completed and a final report is issued. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''u.''' The system fully manages all aspects of laboratory [[LIMS feature#QA/QC functions|quality control]], including the reporting and charting of all quality control data captured in the lab. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''v.''' The system provides a base for a quality assurance program, including proficiency testing, scheduled maintenance of equipment, etc. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''w.''' The system distinguishes QA/QC duplicates from normal samples. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''x.''' The system allows QA/QC tests to be easily created and associated with the primary analytical test. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''y.''' The system allows manual entry of QA and QC data not captured as part of the system's regular processes. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''z.''' The system calculates monthly QA/QC percentages for testing. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''aa.''' The system automatically flags out-of-range quality control limits. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''ab.''' The system is able to flag results for aspects other than being out-of-range, including testing location, test subject age, etc. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''ac.''' The system checks data files for specification and corrects them for specific reporting and analyte limits and qualifiers like dilution factor, automatically assigning qualifiers based on project analyte limiting. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
Line 979: | Line 1,020: | ||
! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''a.''' | | style="padding:5px; width:500px;" |'''a.''' The system bilaterally [[LIMS feature#Instrument interfacing and management|interfaces with instruments]] and related software. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''b.''' | | style="padding:5px; width:500px;" |'''b.''' The system downloads data directly from laboratory instruments. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''c.''' | | style="padding:5px; width:500px;" |'''c.''' The system permits the defining and exporting of sequences to instruments. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''d.''' | | style="padding:5px; width:500px;" |'''d.''' The system tracks and reports on the usage of attached laboratory instruments. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''e.''' | | style="padding:5px; width:500px;" |'''e.''' The system allows automatic or manual reservation/scheduling of laboratory instruments. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''f.''' | | style="padding:5px; width:500px;" |'''f.''' The system automatically (or manually allow an authorized user to) removes an instrument from potential use when it falls out of tolerance limit or requires scheduled calibration. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''g.''' | | style="padding:5px; width:500px;" |'''g.''' The system provides a database of preventative maintenance, calibration, and repair records for laboratory equipment, preferably supported by standardized reporting. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''h.''' | | style="padding:5px; width:500px;" |'''h.''' The system schedules calibration, verification, and maintenance tasks in the worksheets or work flow process and make that schedule available for viewing. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''i.''' | | style="padding:5px; width:500px;" |'''i.''' The system allows users to create and edit instrument maintenance profiles. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
Line 1,026: | Line 1,067: | ||
! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''a.''' | | style="padding:5px; width:500px;" |'''a.''' The system supports a library of common electronic data deliverable (EDD) formats. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''b.''' | | style="padding:5px; width:500px;" |'''b.''' The system transfers data to and from another record management system. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''c.''' | | style="padding:5px; width:500px;" |'''c.''' The system [[LIS feature#Third-party software integration|integrates]] with Microsoft Exchange services. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''d.''' | | style="padding:5px; width:500px;" |'''d.''' The system [[LIMS feature#Import data|imports data]] from and exports data to Microsoft Word, Excel, and/or Access. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''e.''' | | style="padding:5px; width:500px;" |'''e.''' The system can interface with non-Microsoft programs. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''f.''' | | style="padding:5px; width:500px;" |'''f.''' The system interfaces with external billing systems. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''g.''' | | style="padding:5px; width:500px;" |'''g.''' The system interfaces with enterprise resource planning (ERP) systems. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''h.''' | | style="padding:5px; width:500px;" |'''h.''' The system interfaces with external contract or reference laboratories to electronically send or retrieve datasheets, analysis reports, and other related information. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''i.''' | | style="padding:5px; width:500px;" |'''i.''' The system exchanges data with National Identification System (NAIS) tracking systems. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''j.''' | | style="padding:5px; width:500px;" |'''j.''' The system generates and exchanges data with other systems using [[Health Level 7]] (HL7) standards. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''k.''' | | style="padding:5px; width:500px;" |'''k.''' The system leverages the application programming interface (API) of other systems to establish integration between systems. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''l.''' | | style="padding:5px; width:500px;" |'''l.''' The system provides a real-time interface for viewing live and stored data transactions and errors generated by interfaced instruments and systems. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''m.''' | | style="padding:5px; width:500px;" |'''m.''' The system transmits status changes of specimens, inventory, equipment, etc. to an external system. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''n.''' | | style="padding:5px; width:500px;" |'''n.''' The system directs output from ad-hoc queries to a computer file for subsequent analysis by other software. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''o.''' | | style="padding:5px; width:500px;" |'''o.''' The system supports the manual retransmission of data to interfaced systems. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''p.''' | | style="padding:5px; width:500px;" |'''p.''' The system supports [[LIMS feature#Mobile device integration|dockable mobile devices]] and handle information exchange between them and the system. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''q.''' | | style="padding:5px; width:500px;" |'''q.''' The system supports the use of optical character recognition (OCR) software. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
Line 1,105: | Line 1,146: | ||
! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''a.''' | | style="padding:5px; width:500px;" |'''a.''' The system includes a versatile report writer and forms generator that can generate reports from any data in tables. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''b.''' | | style="padding:5px; width:500px;" |'''b.''' The system includes a custom graphic generator for forms. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''c.''' | | style="padding:5px; width:500px;" |'''c.''' The system interfaces with a third-party reporting application. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''d.''' | | style="padding:5px; width:500px;" |'''d.''' The system allows the development of [[LIMS feature#Custom reporting|custom templates]] for different types of reports. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''e.''' | | style="padding:5px; width:500px;" |'''e.''' The system maintains template versions and renditions, allowing management and tracking of the template over time. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''f.''' | | style="padding:5px; width:500px;" |'''f.''' The system generates template letters for semi-annual reports. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''g.''' | | style="padding:5px; width:500px;" |'''g.''' The system supports report queries by fields/keys, status, completion, or other variables. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''h.''' | | style="padding:5px; width:500px;" |'''h.''' The system use Microsoft Office tools for formatting reports. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''i.''' | | style="padding:5px; width:500px;" |'''i.''' The system supports multiple web browsers for viewing online reports. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''j.''' | | style="padding:5px; width:500px;" |'''j.''' The system generates, stores, reproduces, and displays laboratory, statistical, and inventory reports on demand, including narrative. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''k.''' | | style="padding:5px; width:500px;" |'''k.''' The system includes several standard reports and query routines to access all specimens with the pending status through a backlog report that includes the following criteria: all laboratory, department, analysis, submission date, collection date, prep test complete, location, project, specimen delivery group, and other user-selectable options. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''l.''' | | style="padding:5px; width:500px;" |'''l.''' The system indicates whether a report is preliminary, amended, corrected, or final while retaining revision history. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''m.''' | | style="padding:5px; width:500px;" |'''m.''' The system supports both structured and [[LIS feature#Synoptic reporting|synoptic reporting]]. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''n.''' | | style="padding:5px; width:500px;" |'''n.''' The system generates management and turn-around time reports and graphs. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''o.''' | | style="padding:5px; width:500px;" |'''o.''' The system generates customized final reports. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''p.''' | | style="padding:5px; width:500px;" |'''p.''' The system automatically generates laboratory reports of findings and other written documents. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''q.''' | | style="padding:5px; width:500px;" |'''q.''' The system automatically generates individual and aggregate workload and productivity reports on all operational and administrative activities. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''r.''' | | style="padding:5px; width:500px;" |'''r.''' The system automatically generates and transmits exception trails and exception reports for all entered and/or stored out-of-specification data. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''s.''' | | style="padding:5px; width:500px;" |'''s.''' The system generates a read-only progress report that allows for printed reports of specimen status and data collected to date. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''t.''' | | style="padding:5px; width:500px;" |'''t.''' The system provides an ad-hoc web reporting interface to report on user-selected criteria. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''u.''' | | style="padding:5px; width:500px;" |'''u.''' The system automatically generates and updates control charts. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''v.''' | | style="padding:5px; width:500px;" |'''v.''' The system generates QA/QC charts for all recovery, precision, and lab control specimens via a full statistics package, including Levy-Jennings plots and Westgard multi-rule. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''w.''' | | style="padding:5px; width:500px;" |'''w.''' The system displays history of previous results for an analyte's specimen point in a tabular report, graphic trend chart, and statistical summary. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''x.''' | | style="padding:5px; width:500px;" |'''x.''' The system automatically generates and posts periodic static summary reports on an internal web server. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''y.''' | | style="padding:5px; width:500px;" |'''y.''' The system transmits results in a variety of ways including fax, e-mail, print, and website in formats like RTF, PDF, HTML, XML, DOC, XLS, and TXT. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''z.''' | | style="padding:5px; width:500px;" |'''z.''' The system electronically transmits results via final report only when all case reviews have been completed by the case coordinator. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''aa.''' | | style="padding:5px; width:500px;" |'''aa.''' The system includes a rules engine to determine the recipients of reports and other documents based on definable parameters. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''ab.''' | | style="padding:5px; width:500px;" |'''ab.''' The system allows database access using user-friendly report writing and inquiry tools. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
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! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''a.''' | | style="padding:5px; width:500px;" |'''a.''' The system allows the creation, modification, and duplication of user profiles. | ||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''b.''' The system allows entry, maintenance, and administration of [[LIMS feature#Customer, supplier, and physician management|customers]], suppliers, and other outside entities. | |||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''c.''' The system allows customers, suppliers, and other such entities to be flagged as either active or inactive. | |||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''d.''' The system allows the creation, modification, and maintenance of user [[LIMS feature#Performance evaluation|training records]] and associated training materials. | |||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''e.''' The system supports the ability to set up separate security, inventory, reporting, etc. profiles across multiple facilities. | |||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''f.''' The system allows the management of information workflow, including notifications for requests and exigencies. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''g.''' The system allows the [[LIMS feature#Document creation and management|management of documents]] like SOPs, MSDS, etc. to better ensure they are current and traceable. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''h.''' The system allows the management and monitoring of resources by analyst, priority, analysis, and instrument. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''i.''' The system allows authorized persons to select and assign tasks by analysts, work group, instrument, test, sample, and priority. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''j.''' The system allows authorized persons to review unassigned work by discipline and by lab. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''k.''' The system allows authorized persons to review pending work by analyst prior to assigning additional work. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''l.''' The system manages and reports on reference samples, reagents, and other inventory, including by department. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''m.''' The system automatically warns specified users when [[LIMS feature#Inventory management|inventory counts]] reach a definable threshold and either prompt for or process a reorder. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''n.''' The system allows authorized users to monitor and report on reference and reagent creation, use, and expiration. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''o.''' The system allows authorized users to search [[LIMS feature#Billing and revenue management|invoice information]] by invoice number, account number, accession, payment types, client, or requested diagnostic test(s). | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''p.''' The system includes [[LIMS feature#Performance evaluation|performance assessment]] tracking. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''q.''' The system receives, records, and maintains customer and employee feedback and applies tools to track the investigation, resolution, and success of any necessary corrective action. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''r.''' The system includes an incident tracking system for recording, investigating, and managing safety and accident violations in the laboratory. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''s.''' The system monitors proficiency test assignment, completion, and casework qualification for analytical staff. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''t.''' The system includes revenue management functionality, including profitability analysis. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''u.''' The system provides analysis tools to better support laboratory functions like resource planning, productivity projections, workload distribution, and work scheduling, and those tools display information in a consolidated view, with the ability to drill down to more detailed data. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''v.''' The system calculates administrative and lab costs. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''w.''' The system captures and maintains patient, submitter, supplier, and other client demographics and billing information for costing, invoicing, collecting, reporting, and other billing activities. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''x.''' The system supports multiple customer [[LIS feature#Billing and revenue management|payment sources]] (e.g. grants). | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |''' | | style="padding:5px; width:500px;" |'''y.''' The system tracks number of visits per specific industry. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
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==1.5 System-specific== | ==1.5 System-specific== | ||
The system-specific addendum [[LIMS and laboratory informatics questionnaire/1.5 System-specific|can be found here]]. | The system-specific addendum [[LII:LIMS and laboratory informatics questionnaire/1.5 System-specific|can be found here]]. | ||
==1.6 Industry-specific== | ==1.6 Industry-specific== | ||
The industry-specific addendum [[LIMS and laboratory informatics questionnaire/1.6 Industry-specific|can be found here]]. | The industry-specific addendum [[LII:LIMS and laboratory informatics questionnaire/1.6 Industry-specific|can be found here]]. | ||
==1.7 Custom requirements== | ==1.7 Custom requirements== | ||
{| | {| | ||
| STYLE="vertical-align:top;"| | | STYLE="vertical-align:top;"| | ||
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" | {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width="1300px" | ||
|- | |- | ||
! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px; width:1300px;"| 1.7 '''Custom requirements''' | ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px; width:1300px;"| 1.7 '''Custom requirements''' | ||
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|} | |} | ||
|} | |} | ||
<!---Place all category tags here--> | |||
[[Category:Unmaintained or defunct guides, white papers, and other publications]] |
Latest revision as of 00:04, 12 April 2024
The intention of this document is 1. to assist labs searching for a laboratory informatics product with identifying their system needs and 2. to help labs better determine if a specific vendor/product meets their requirements in the form of a request for information (RFI). The idea is to allow users to incorporate a standardized specifications sheet in their comparison of various LIMS and other laboratory informatics products.
This questionnaire lists the extensive requirements of a LIMS as well as other laboratory informatics systems. (See below for more about this.) The questionnaire is organized such that sections 1.0 through 1.4 offer questions applicable to most any laboratory informatics system, be it a LIMS or an ELN. Section 1.5 covers functionality found specifically in software systems other than LIMS.
This questionnaire is comprehensive and includes many items that do not apply to every lab. Additionally, some laboratories' requirements include a functionality item not common to other labs. Section 1.6 "Industry-specific" contains a selection of those industry-specific requirements and will continue to be amended over time. The last section, 1.7 "Custom functions," is designed for the vendor to insert any additional functionality that doesn't fall under the categories provided.
When referencing a particular item for someone else, use the section number followed by the requirement letter, e.g. 1.4.2.f for "Does your system allow the administrator to create custom screens, applications, and reports? Please give details."
More about this questionnaire
As noted above, this questionnaire was originally designed to cover aspects of a laboratory information management system (LIMS). However, a significant portion of this page if not most of it could easily apply to other laboratory informatics systems like ELNs. As such, we took the approach of adding addenda (as seen in section 1.5 and 1.6) that provide additional requirements unique to other systems and industries. If you're evaluating several industry-neutral LIMS, you likely don't need 1.5 and 1.6.
Requirement code and notes
In responding to each requirement, the vendor must select a requirement code from the following:
- Y: Meets requirement in commercial off-the-shelf solution as delivered/configured (or vendor provides service)
- YC: Meets requirement only with customization (additional code, using a third-party application, etc.)
- N: Does not meet requirement
- I: Informational response only, N/A
The vendor should ideally enter a requirement code and a response for each functionality question.
Printing or saving
The print/export options in the navigation on the far left give you a few options for saving this and other pages, printing them for later.
Notice you'll have to open 1.5 and 1.6 in separate pages to view, print, and save them.
Note: Tables are currently not being rendered in PDFs as we like through the MediaWiki Collection extension. While we sure would love for you to make a PDF of this document, be warned: the tables don't format as intended, using either the "Create a book" or "Download as PDF" processes. For now you're best off selecting "Printable version" and printing that instead.
1.0 Vendor information
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1.1 Vendor services
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1.2 Information technology
1.2.1 General IT
1.2.2 Hardware environment
1.2.3 Software environment
1.3 Regulatory compliance and security
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