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  1. The Laboratory Test Results (LB) domain captures laboratory data collected by the lab executing the study or data received from a central provider.
  2. Results definition:
    1. LBSTRESC (or corresponding numeric LBSTRESN) is used to represent standardized format of original results. For instance, original results such as "NEG" or "NEGATIVE" may be represented in standard format as "NEGATIVE" in LBSTRESC.
    2. LBORNRLO and LBORNRHI represent the reference range in original units, and LBSTNRLO and LBSTNRHI represent the reference range in standard units. These variables are permissible, since many tests may not have well-established ranges or the ranges would not apply.
    3. For lab tests that do not have continuous numeric results (e.g., urine protein as measured by dipstick, descriptive tests such as urine color), LBSTNRC could be populated either with normal character range values in an ordinal scale (e.g., "NEGATIVE to TRACE") or a delimited set of values that are considered to be normal (e.g., "YELLOW", "AMBER").
    4. LBSTAT and LBREASND are permissible and are used to indicate when a test was not completed. In these cases, LBSTAT should contain "NOT DONE"; LBORRES, LBSTRESC, and LBSTRESN should be null. LBREASND should contain the reason for not completing the test.
  3. Specimen collection location - organ/tissue definition:
    1. The location of specimen collection for a subject is described by the following fields: LBSPEC, LBANTREG, and LBLOC.
    2. LBSPEC is Expected and defines the specimen type or the base organ or tissue analyzed.
    3. LBANTREG is permissible and further specifies a part or section of the organ/tissue specified in LBSPEC. Examples include the cortex of the kidney or a study-specific sectioning of the organ (e.g., top section of left liver lobe).
    4. LBLOC is permissible to specify location of specimen collection. If a sample of blood is taken, LBLOC may be used to indicate the location of sampling (e.g., jugular vein, portal vein). Another example could be if the specimen type (LBSPEC) is "BONE MARROW"; LBLOC could be "Femoral" or "Sternal".
  4. Timing variables:
    1. Information about the time of collection for any observation is needed to identify the record. LBDTC is expected, and the data will, in most cases, contain LBDTC, LBDY, or both. However, some studies (e.g., legacy studies) may not collect LBDTC or LBDY; in such cases, LBNOMDY must be populated.
    2. For lab tests where the specimen is collected over time (e.g., 24-hour urine collection), the start date/time of the collection goes into LBDTC and the end date/time of collection goes into LBENDTC.
  5. Pooling:
    1. For lab results that correspond to samples pooled from different subjects, POOLID will be populated with a unique number identifying the pool (see Section 8.5.1, Pool Definition - POOLDEF).
    2. One record will exist for each pool in LB. Populating POOLID will mark the result as being collected at a pool level and not on a subject level.
  6. Other assumptions:
    1. A value derived by a lab according to their procedures is considered as having an origin value of collected, rather than derived.
    2. A single reference range can be included for either standard results (LBSTNRLO and LBSTNRHI) or original results (LBORNRLO and LBORNRHI), but not both. LBNRIND is used as a reference range indicator for the range being used.

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