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| Requirement and response
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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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