This tab enables users to define new types of laboratory Tests and edit existing ones.
Users can search for existing Tests by name, category, alias, method, or target. Searches return Tests that contain the closest exact matches to the specified search query.
The table on this Tests page displays a brief summary on every existing Test including name, alias, categories, Test method, target, container type, and minimum required volume (mL).
Creating a new Test
By clicking on the ‘+ Test’ button in the top right of the screen, users will be taken to a form for creating a new Test.
This Test create form has the following options and requirements, with mandatory fields being denoted with a red asterisk:
- Method refers to the type of experimental method that will be used to perform the Test (Ex. LC-MS, PCR, WB, etc.). This field is used to sort Test results into different sections on the Order details page and on the Order report.
- Analyte or Target refers to the target or analyte that will be measured by the Test.
- Report Templates are used to determine how the Test and Test results should be displayed on the Order report PDF.
- Test Categories are the organizational labels that are used to arrange and visually display Tests on any pages where users must select individual Tests.
- Test Name must be unique.
- Reportable Name is an optional field that, if provided, will be used in results reports instead of Test Name.
- Alternate ID is an optional field for storing external IDs for test types, similar to how you can have Alternate IDs for Orders. A good usage example is for IDs assigned by compendium mappings. Alternate IDs for Tests must be unique.
- Users may specify Aliases that represent common names / alternative names for the Test.
- Lab Department/Section field enables users to specify different client lab departments that they’d like to associate the Test with. Lab departments represent different internal working groups within the client lab and are different from in-house lab locations, which represent different geographic locations for client sites.
- Manufacturer allows the user to specify the company that manufactured the Test.
- Isotype and Band fields are specific to antibody-based Tests.
- Required Turnaround Time can be specified in days, hours, or minutes and refers to the speed at which a given Test should be processed. This value is used to calculate the Test’s due date on an Order.
- Result Type is used to indicate whether the Test should return a quantitative result (a number) or a qualitative result (a label).
- When checked, Hide Quantitative Result Value on Report makes it such that reports contain only qualitative values for the Test at hand.
- Dropdown options for Reference Type dropdown options are “Cutoff” or “Reference Ranges”, used to indicate whether the Test will use reference ranges or a single binary cutoff value.
- Positive/Detected above cutoff outside of reference range is checked for Tests where a quantitative result value above a set cutoff is used to indicate a positive/detected result. If left unchecked, then a quantitative result value below the set cutoff will indicate a positive/detected result.
- The Calculated Result field should only be checked for Tests where the result of the Test will be based on a calculation performed on the results of several other Tests.
- The Unit of Measurement field indicates the units that should be used by the result values for the Test.
- If the Use Round Figures boolean field is checked, then the Test will store quantitative results figures as rounded values rather than exact values.
- The Acceptable Sample Types multi-select field is used to indicate what sample types the Test can be run on. This field is used to filter out selectable Tests during the Order create process.
- The Acceptable Container Types multi-select field is used to indicate what container types the Test can be run with. This field is used to filter out selectable Tests during the Order create process.
- The Minimum Required Volume (mL) field is used during the Order Create process to automatically calculate how many containers of a given container type are required to run a Test.
- The Shipping Temperature contains qualitative classifications for the temperature at which samples should be shipped. If a sample’s sample temperature field does not match a Test’s shipping temperature then it will be flagged by the LIS.
- The Medical Necessity Codes multi-select field is used to select ICD-10-CM codes to associate with the Test. These codes are a standardized set of national codes used to determine what specific medical conditions to associate with a given Test.
- The LOINC Code field is used to set a LOINC Code for a given Test. This identifier is part of a universal standard classification system for identifying medical observations. Similarly, LOINC Fully Specified Name and LOINC Long Common Name can also be filled out.
- The Research Use Only boolean field is used to indicate whether the Test should only be used for research purposes. A Test that is a research use only will not have a reference value for determining positive/detected cutoffs.
- The Internal Test boolean field is used to indicate whether the Test is internal to the client site. An internal Test will not be reported on an Order’s report.
Test Details page
After creating a Test, users will be redirected to the Test details page.
The Test details page displays user-specified information on the Test and also enables the user to delete, edit, or add internal comments to the Test.
From the Test details page, the user can also create reflexes, set reference ranges, or add calculations for calculated Tests.
Qualitative Result Values
You can configure result display values for Tests instead of the Dendi-provided default values. The possible result values differ for Cutoff vs Reference Range Tests.
- For Cutoff-based Tests, Dendi has four qualitative results. These default values are “Detected”, “Not Detected”, “Equivocal”, and “Indeterminate”.
- Similarly, Reference Range-based Tests have three default qualitative results: “Above Range”, “Within Range”, and “Below Range”.
For a given Test, you can choose which results are available for selection. You are also able to configure the label value for results (for example, “Positive” instead of “Detected”). If you choose to set specific configured values, these will show up on reports. There is a maximum character length of 24 for configured values.
You can also add your own custom qualitative result values. These custom values are selectable when resulting manually from the Order Details page, and will show up on reports as configured. Custom qualitative result values have to be unique.
In the same section, you are also able to specify SNOMED-CT codes for qualitative results. These values are freeform and have no validation other than being alphanumeric. These values will be used for state reporting CSVs/HL7 messages. If you do not specify a SNOMED-CT code, the default code associated with the configured result value will be used.
Reflexes can be set on the Test details page.
A reflex consists of two main parts: a trigger and a reflex Test Profile. The trigger for the reflex is a specific Test result value that must be met in order for the reflex to activate. Every time a Test that has an associated reflex is saved on an Order, the LIS checks to see if the result value meets the trigger criteria.
When a reflex is activated, the specified reflex Test Profile is added to the Order. Although a Test may have multiple reflexes, reflex ranges cannot overlap or be redundant.
Reflexes can be added for both qualitative and quantitative Test types. Users can also add notes to be associated with the reflex.
Reference ranges for a Test can be set on its Test details page.
Reference Ranges are directly under the test details section and users can set reference range rules that will apply differently to patients depending on their demographics such as age, race, or sex.
When a Test result is saved, the most specific reference range that applies to that particular instance of the Test will be applied to determine if the Test result is within the reference range.
Different Reference Range Rules can have separate Reference Ranges, ie. creatinine levels in men vs women, different calculations, and different flags.
Users can add as many reference ranges as they wish, but reference ranges within each rule cannot overlap. Each reference range can be set as expected or not expected and given its own flag, which will change how they appear on the report.
Additionally, each reference range can have a SNOMED Code, Flag, a Report Comment associated with it. The SNOMED code will be used on certain state reports, and the flag and report comment will populate the final report in the generic report template.
If the reference range zone is marked as an expected value, the result will appear in black text on a final report, and if it is not, the result will appear in red.
Note: Default range rules cannot be archived while specific Account/Race/Gender/Age rules exist.
Reportable ranges allow you to determine valid results on a given Test for a given instrument. Upper/Lower Limits of Quantification (ULOQ/LLOQ) are tied to reportable ranges rather than reference ranges. One way to think about this is that reportable ranges are “analytically-based”, while reference ranges are “human-based”.
For a given Reportable Range rule, you must set at least one of Lower Limit or Upper Limit. Having values for both Lower Limit and Upper Limit is permissible.
Calculated results can be set on the Reference Range details page for any Tests that have the Calculated Result boolean field set to true.
For any Test with a calculated result, users must first select the Tests that will be used to calculate the result value.
For qualitative Tests, results are calculated via a truth table. Every combination of results for the aforementioned selected Tests is displayed in the truth table and the calculated qualitative result for every one of these combinations can be set in the truth table. Users can then decide on the final Result Interpretation given the combination of the constituent results.
For quantitative Tests, results are calculated via a calculation formula. The aforementioned selected Tests are each automatically assigned to a variable. These variables can be used in combination with a standard set of mathematical operators to create a calculation formula.
When values for all the required Tests for a calculated Test result are saved on an Order, then the result calculation is performed automatically.
Only a single calculation formula or truth table may exist for a Test at a time.
Here is a demo video on how to create a Test on the LIS