User:Shawndouglas/sandbox/sublevel40

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1. Sample and experiment registration

Requirement and response
1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.
 


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1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.
 


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1.3 The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.
 


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1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.
 


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1.5 The system should permit metadata like lot number, client demographics, sampling point, random selection process used, and industry-specific items to be included during registration.
 


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1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
 


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1.7 The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.
 


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1.8 The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.
 


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1.9 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.
 


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1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.
 


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1.11 The system should support the creation of user-definable default sample registration preferences and/or input screens.
 


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1.12 The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.
 


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1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.
 


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1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.
 


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1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.
 


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1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.
 


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1.17 The system should provide a means to document sample preparation activities for a given sample.
 


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1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel—including details such as unique identifier, name, location, date, and time—while the sample is in the laboratory’s possession.
 


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1.19 In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.
 


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2. Sample management

Requirement and response
2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
 


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2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.
 


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2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
 


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2.4 The system shall require the recording of a standard and reagent's first opening date.
 


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2.5 The system shall allow only active standards and reagents to be shown as available for use.
 


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2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
 


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2.7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status.
 


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2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.
 


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2.9 The system should provide a means to manually or automatically track sample inventory amounts and status.
 


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2.10 The system shall be able to link test methods and specifications to standards and reagents.
 


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2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
 


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3. Core laboratory testing and experiments

Requirement and response
3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.
 


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3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.
 


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3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.
 


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3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.
 


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3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.
 


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3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.
 


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3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.
 


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3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.
 


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3.9 The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.
 


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3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.
 


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3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.
 


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3.12 The system should effectively alert users upon entry of out-of-specification test results.
 


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3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.
 


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4. Results review and verification

Requirement and response
4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
 


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4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.
 


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4.3 The system shall accurately maintain a full audit trail for modified results.
 


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4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.
 


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4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.
 


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4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.
 


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5. Sample, experiment, and study approval and verification

Requirement and response
5.1 The system shall accurately record details of a sample's final disposition.
 


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5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.
 


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5.3 The system should provide appropriate functions for specific sample statuses like "approved" and "rejected," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.
 


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6. Reporting

Requirement and response
6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.
 


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6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format—such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file—as well as PDF format, for reporting purposes.
 


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6.3 The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.
 


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6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., "less than X mg/L") when doing so would provide relevant information to the report recipient.
 


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6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
 


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6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.
 


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6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.
 


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6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.
 


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6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.
 


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