Enable PMDA E2B(R3): Prevent Export of Unsupported UCUM Codes

Learn how to configure your Vault to prevent the export of unsupported UCUM codes on PMDA E2B(R3) reports.

About the Feature

With the 24R2 release, Vault Safety prevents the export of unsupported Unified Code for Units of Measure (UCUM) codes to PMDA E2B(R3) reports. Vault considers a code to be unsupported if the related unit of measurement is not listed in the Agency Units of Measurement object for the PMDA agency. This feature reduces instances of PMDA E2B(R3) files being rejected for unsupported codes and the need to route corrections to Global Case Processors.

When a Global or Domestic Case includes any Strength, Dose, or Cumulative Dose to First Reaction units of measurement that are not supported by the PMDA, those unsupported units are captured in a Validation Criteria record. Depending on your configuration, unsupported units of measurement may be excluded completely or Vault can export those unit values as {DF}. If a unit is excluded, the associated number value is also excluded from the export.

This change impacts the following PMDA E2B(R3) data elements:

  • G.k.2.3.r.3a Strength (number) and G.k.2.3.r.3b Strength (unit)
  • G.k.4.r.1a Dose (number) and G.k.4.r.1b Dose (unit)
  • G.k.5a Cumulative Dose to First Reaction (number) and G.k.5b Cumulative Dose to First Reaction (unit)

After enabling this feature, see Prevent Export of Unsupported UCUM Codes in Report to the PMDA.

Prerequisite

You must have enabled Support for Unconstrained UCUM for Test Result Units.

Configure Export of Unsupported UCUM Codes

There are two (2) settings that control how Vault manages unsupported UCUM codes as follows:

  • PMDA E2B: Do not export UCUM code not supported by PMDA: When selected, this setting prevents the export of unsupported UCUM codes to PMDA E2B(R3) reports.
  • Export {DF} for unsupported UCUM code if number is specified: This option is available only when the PMDA E2B: Do not export UCUM code not supported by PMDA option is selected. When selected, this setting exports {DF} in place of unsupported UCUM codes on PMDA E2B(R3) reports.

Complete the steps below to configure these settings in your Vault.

  1. Go to Admin > Settings > Submission and Distribution Settings and select Edit.
  2. Select the PMDA E2B: Do not export UCUM code not supported by PMDA checkbox.
    A subsetting appears.
  3. Optional: Select the Export {DF} for unsupported UCUM code if number is specified checkbox.
  4. Select Save.

Once this feature is enabled, we recommend setting the following Validation Criteria for unsupported UCUM codes to Inactive:

  • PMDA.G.k.2.3.r.3b
  • PMDA.G.k.4.r.1b
  • PMDA.G.k.5b
  1. Go to Business Admin > Objects > Validation Criteria.
  2. In the Agency column filter, select the PMDA checkbox and then select Apply.
  3. For each Validation Criteria listed above, select the record and change its object status from Active to Inactive.
    1. On the Change Object Status dialog, select Yes.